Critical IllnessPhase 3NCT00078663
Oral Care to Reduce Mouth and Throat Infections in Critically Ill Patients
A Phase 3 study testing Oral Care in people with Critical Illness, run by National Institutes of Health Clinical Center (CC) at 5 sites in United States.
Trial summary
This study will evaluate whether a program of systematic oral care can help prevent hospital-acquired respiratory infections in patients in intensive care units. Such infections occur five times more often in critically ill patients compared with patients in general hospital wards and result in longer hospital stays… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Oral Care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Mar 2004to 16 Aug 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adult ICU patients whose oral hygiene is dependent upon hospital care providers.
- Expected length of ICU stay is greater than or equal to 3 days.
- Any gender and ethnicity.
Who cannot join
- Individuals and or responsible family members who are unable to provide consent.
- Any individual under the age of 18 years.
- Any individual whose expected admission is less than 3 days.
- Adult ICU patients whose admission CPIS score is greater than 6.
- Individuals who are able to provide own oral care.
- Individuals who have oral surgery that requires specialized oral care and assessment.
Show all 9Show fewer
- Edentulous patients.
- Any patient with a prosthetic heart valve or who routinely takes prophylactic antibiotics before routine dental procedures.
- Any patient with a known allergy to chlorhexidine.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Suburban Hospital
Bethesda, Maryland, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Inova Fairfax Hospital
Fairfax, Virginia
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Winchester Medical Center
Winchester, Virginia
About this study
Official title: The Effect of a Systemic Oral Care Program on Reducing Exposure to Oropharyngeal Pathogens in Critically III Patients
This study will evaluate whether a program of systematic oral care can help prevent hospital-acquired respiratory infections in patients in intensive care units. Such infections occur five times more often in critically ill patients compared with patients in general hospital wards and result in longer hospital stays and an increased risk of death. The rate of respiratory infection among critically ill patients correlates strongly with the presence of disease-causing bacteria in the mucosal areas of the mouth, gums, and teeth, indicating that assiduous oral care is especially important in this patient population. This study will compare a program of meticulous oral care using oral assessments taught by a dentist and dental hygienist with the standard care typically given in intensive care units.
Critically ill patients 18 years of age and older who are hospitalized in an intensive care unit for 3 or more days and whose oral hygiene is dependent on hospital care providers may be eligible for this study. Patients will be recruited from intensive care units at four Washington, D.C., area hospitals - Suburban Hospital, Washington Hospital Center, Inova Fairfax Hospital, and Winchester Medical Center.
Participants will have their lips, mouth, gums, teeth, and saliva examined several times a day to determine their optimum oral care. They will receive standard care, such as flossing, brushing, rinsing with a mouthwash, and possibly use of an antiseptic spray that prevents bacteria from clinging to the teeth. Small samples of saliva (less than one-fourth of a teaspoon) and dental plaque will be collected the day the patient is admitted to the intensive care unit and again on days 3 and 5 of their stay in the unit. The saliva sample is collected with a small suction tube placed in the corner of the mouth; the plaque specimen is collected by gliding a tiny piece of paper over the surface of a front tooth. The samples will be examined for any bacteria not normally found in saliva.
Read the detailed description
Critically ill patients, especially those that require endotracheal intubation, have the greatest risk of any hospitalized patient for acquiring nosocomial pneumonia. Nosocomial pneumonia, in this population, produces a substantial increase of mortality and morbidity. The literature suggests the causative pathway is aspiration of oropharyngeal pathogens found in dental plaque. The build-up of dental plaque has been significantly associated with subsequent nosocomial respiratory infections. Thus, prevention of pathogens colonization in the oropharyngeal cavity could be an effective infection control measure.
Dental plaque once it reaches a critical thickness, acts as a reservoir for both aerobic and anaerobic pathogens. Failure to remove plaque begins a complex cascade of biological activity by which pathogens adhere to mucosal and tooth surfaces and pathogen overgrowth ensues. Additionally, neglected or insufficient mouth care is the foremost predisposing factor to oral conditions such as gingivitis, mucositis, and stomatitis which supply additional ports of entry for pathogens.
There are only a handful of studies that compare the frequency and type of oral hygiene required to prevent or decrease oropharyngeal colonization. A recent pilot study, 01-CC-0207, compared oral care provision in two intensive care units (ICU) in the Clinical Center. The test ICU offered meticulous oral hygiene through a system of regular oral assessments taught by a dentist and dental hygienist. The score from the assessment determined the type and frequency of oral care. The control ICU gave standard care typical of the ICU community. Plaque and saliva assays were collected from the enrolled patients. Significantly lower Beck scores and lower colony forming organisms in the specimens was achieved in the test ICU on day 3, p less than 0.03 and p less than 0.001 respectively.
This protocol will expand the pilot into a prospective randomized assigned trial conducted at four hospitals in the Washington D.C. area. These hospitals have ICUs more representative of ICU's nation-wide. This study will test the effectiveness of a comprehensive and systematic oral care program to reduce the oral assessment scores, mucosal plaque scores, and the amount of pathogen inoculum present in the saliva and plaque. Intubated and non-intubated patients will be compared as well as meticulous care with or without the addition of the oral antiseptic, chlorhexidine. Consistency of practice performance will also be evaluated when nursing staff has dentist/hygienist instruction and monitoring versus the traditional nurse instruction.
- Conditions
- Critical Illness
- Being tested
- Oral Care
- Keywords
- Oral Care, ICU, Pneumonia, Pathogens, Intubation, Intubated, Oral Hygiene, Intensive Care
- Medical subject headings
- Critical Illness, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral CareBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2004 (estimated)
- Study start2 Mar 2004
- Primary completion28 Dec 2007
- Study completion16 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078663
- Sponsor's protocol ID
- 040130
- Other IDs
- 04-CC-0130
- Status last verified
- 16 Aug 2011
- First submitted
- 3 Mar 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Collard HR, Saint S, Matthay MA. Prevention of ventilator-associated pneumonia: an evidence-based systematic review. Ann Intern Med. 2003 Mar 18;138(6):494-501. doi: 10.7326/0003-4819-138-6-200303180-00015.
PubMed 12639084Valles J, Mesalles E, Mariscal D, del Mar Fernandez M, Pena R, Jimenez JL, Rello J. A 7-year study of severe hospital-acquired pneumonia requiring ICU admission. Intensive Care Med. 2003 Nov;29(11):1981-8. doi: 10.1007/s00134-003-2008-4. Epub 2003 Sep 10.
PubMed 13680109Eggimann P, Hugonnet S, Sax H, Touveneau S, Chevrolet JC, Pittet D. Ventilator-associated pneumonia: caveats for benchmarking. Intensive Care Med. 2003 Nov;29(11):2086-9. doi: 10.1007/s00134-003-1991-9. Epub 2003 Sep 3.
PubMed 12955177
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Systemic Oral Care Program on Reducing Exposure to Oropharyngeal Pathogens in Critically III Patients
- ClinicalTrials.gov ID
- NCT00078663
- Acronym / sponsor ID
- 040130
- Conditions
- Critical Illness
- Keywords
- Oral Care, ICU, Pneumonia, Pathogens, Intubation, Intubated, Oral Hygiene, Intensive Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 2 Mar 2004
- Primary completion
- 28 Dec 2007 (actual)
- Study completion
- 16 Aug 2011 (actual)
- First posted
- 4 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether a program of systematic oral care can help prevent hospital-acquired respiratory infections in patients in intensive care units. Such infections occur five times more often in critically ill patients compared with patients in general hospital wards and result in longer hospital stays and an increased risk of death. The rate of respiratory infection among critically ill patients correlates strongly with the presence of disease-causing bacteria in the mucosal areas of the mouth, gums, and teeth, indicating that assiduous oral care is especially important in this patient population. This study will compare a program of meticulous oral care using oral assessments taught by a dentist and dental hygienist with the standard care typically given in intensive care units.
Critically ill patients 18 years of age and older who are hospitalized in an intensive care unit for 3 or more days and whose oral hygiene is dependent on hospital care providers may be eligible for this study. Patients will be recruited from intensive care units at four Washington, D.C., area hospitals - Suburban Hospital, Washington Hospital Center, Inova Fairfax Hospital, and Winchester Medical Center.
Participants will have their lips, mouth, gums, teeth, and saliva examined several times a day to determine their optimum oral care. They will receive standard care, such as flossing, brushing, rinsing with a mouthwash, and possibly use of an antiseptic spray that prevents bacteria from clinging to the teeth. Small samples of saliva (less than one-fourth of a teaspoon) and dental plaque will be collected the day the patient is admitted to the intensive care unit and again on days 3 and 5 of their stay in the unit. The saliva sample is collected with a small suction tube placed in the corner of the mouth; the plaque specimen is collected by gliding a tiny piece of paper over the surface of a front tooth. The samples will be examined for any bacteria not normally found in saliva.
Detailed description
Critically ill patients, especially those that require endotracheal intubation, have the greatest risk of any hospitalized patient for acquiring nosocomial pneumonia. Nosocomial pneumonia, in this population, produces a substantial increase of mortality and morbidity. The literature suggests the causative pathway is aspiration of oropharyngeal pathogens found in dental plaque. The build-up of dental plaque has been significantly associated with subsequent nosocomial respiratory infections. Thus, prevention of pathogens colonization in the oropharyngeal cavity could be an effective infection control measure.
Dental plaque once it reaches a critical thickness, acts as a reservoir for both aerobic and anaerobic pathogens. Failure to remove plaque begins a complex cascade of biological activity by which pathogens adhere to mucosal and tooth surfaces and pathogen overgrowth ensues. Additionally, neglected or insufficient mouth care is the foremost predisposing factor to oral conditions such as gingivitis, mucositis, and stomatitis which supply additional ports of entry for pathogens.
There are only a handful of studies that compare the frequency and type of oral hygiene required to prevent or decrease oropharyngeal colonization. A recent pilot study, 01-CC-0207, compared oral care provision in two intensive care units (ICU) in the Clinical Center. The test ICU offered meticulous oral hygiene through a system of regular oral assessments taught by a dentist and dental hygienist. The score from the assessment determined the type and frequency of oral care. The control ICU gave standard care typical of the ICU community. Plaque and saliva assays were collected from the enrolled patients. Significantly lower Beck scores and lower colony forming organisms in the specimens was achieved in the test ICU on day 3, p less than 0.03 and p less than 0.001 respectively.
This protocol will expand the pilot into a prospective randomized assigned trial conducted at four hospitals in the Washington D.C. area. These hospitals have ICUs more representative of ICU's nation-wide. This study will test the effectiveness of a comprehensive and systematic oral care program to reduce the oral assessment scores, mucosal plaque scores, and the amount of pathogen inoculum present in the saliva and plaque. Intubated and non-intubated patients will be compared as well as meticulous care with or without the addition of the oral antiseptic, chlorhexidine. Consistency of practice performance will also be evaluated when nursing staff has dentist/hygienist instruction and monitoring versus the traditional nurse instruction.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female adult ICU patients whose oral hygiene is dependent upon hospital care providers.
- Expected length of ICU stay is greater than or equal to 3 days.
- Any gender and ethnicity.
Key exclusion criteria (9 listed)
- Individuals and or responsible family members who are unable to provide consent.
- Any individual under the age of 18 years.
- Any individual whose expected admission is less than 3 days.
- Adult ICU patients whose admission CPIS score is greater than 6.
- Individuals who are able to provide own oral care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Care | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 12639084Collard HR, Saint S, Matthay MA. Prevention of ventilator-associated pneumonia: an evidence-based systematic review. Ann Intern Med. 2003 Mar 18;138(6):494-501. doi: 10.7326/0003-4819-138-6-200303180-00015.
- Background: PubMed 13680109Valles J, Mesalles E, Mariscal D, del Mar Fernandez M, Pena R, Jimenez JL, Rello J. A 7-year study of severe hospital-acquired pneumonia requiring ICU admission. Intensive Care Med. 2003 Nov;29(11):1981-8. doi: 10.1007/s00134-003-2008-4. Epub 2003 Sep 10.
- Background: PubMed 12955177Eggimann P, Hugonnet S, Sax H, Touveneau S, Chevrolet JC, Pittet D. Ventilator-associated pneumonia: caveats for benchmarking. Intensive Care Med. 2003 Nov;29(11):2086-9. doi: 10.1007/s00134-003-1991-9. Epub 2003 Sep 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral Care in people with Critical Illness, run by National Institutes of Health Clinical Center (CC) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00078663, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.